R-010-002 Approved Suppliers List
- Governed by
GP-010 Purchases and suppliers evaluation
Revision historyβ
| Version | Date | Description | Author |
|---|---|---|---|
| 1.0 | 2024-02-13 | Initial release. Approved suppliers list established. | JD-004 |
| 2.0 | 2025-01-13 | Annual review. All suppliers re-approved without changes. | JD-004 |
Purposeβ
General list of all approved suppliers, their type, criticality classification, and current approval status. This list is reviewed and re-evaluated annually during the Management Review.
Approved suppliers listβ
21
Total suppliers
7
CIV
14
NIV
7
Critical
| # | Code | Supplier Name | Service/Product | Type | Critical | Approval Date | Next Review | Status |
|---|---|---|---|---|---|---|---|---|
| 1 | S-AMA | Amazon Web Services, Inc | Cloud services (AWS) | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 2 | S-ATL | Atlassian Corporation | Project management, code collaboration (Jira, Confluence, Bitbucket) | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 3 | S-GOO | Google LLC | Google Workspace | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 4 | S-PSC | PS Consulting | Regulatory and Quality services | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 5 | S-AUD | Audens | Legal services | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 6 | S-STR | Stripe, Inc | Payment processing | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 7 | S-IDI | iDISC Information Technologies, S.L. | Translation services | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 8 | S-LAW | Lawesome | Legal services | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 9 | S-HUB | HubSpot, Inc. | CRM, Marketing | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 10 | S-HOL | Holded Technologies | Accounting software | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 11 | S-FAC | Factorial | HR management | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 12 | S-SLA | Slack Technologies, Salesforce Inc | Team communication | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 13 | S-APO | Apotech Consulting | Consulting services | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 14 | S-BSI | BSI | Certification body | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 15 | S-MIC | Microsoft | Development tools (GitHub, VS Code, Azure) | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 16 | S-GLA | GL AI INVESTMENT | AI services | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 17 | S-DOC | Docker, Inc. | Container platform | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 18 | S-CMG | CMG MedDev | Regulatory consulting | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 19 | S-DME | Dmed software | Medical device software services | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 20 | S-DES | Design science | Design services | CIV | β | 2025-01-13 | 2026-04-01 | Approved |
| 21 | S-BRA | Brazil Import Healthcare Solutions | Distribution services | NIV | β | 2025-01-13 | 2026-04-01 | Approved |
Type definitions:
- NIV: Non-Impact Vendor
- CIV: Controlled Impact Vendor
- NIS: Non-Impact Subcontractor
- CIS: Controlled Impact Subcontractor
- HRIV: High-Risk Impact Vendor (cannot be approved)
- HRIS: High-Risk Impact Subcontractor (cannot be approved)
Criticality:
- β Critical: Supplier directly impacts the safety, performance, or regulatory compliance of the medical device
- β Non-critical: Supplier does not directly impact the medical device quality
Notesβ
- All CIV suppliers are considered critical as they directly impact development or production of the medical device
- Annual review scheduled during Management Review
Record signature meaningβ
- Author: JD-004 MarΓa Diez
- Review: JD-005 Alfonso Medela
- Approval: JD-001 Andy Aguilar γ €